Associate Principal Scientist, Medical Safety Review Physician-5

Job Description

Under the direction and oversight of the ICMR Leadership the ICMR Physician will:

• As required per SOP, provide in-line medical review of individual case safety reports (ICSRs) arising from our Company clinical trials and other sources, as required, and will include the following actions: Determine or confirm the need for expedited reporting to regulatory agencies, ensure the quality coherence, and accuracy of the case narrative, performs a medical assessment of the case in the context of the available safety data and the known safety profile, and provide a company statement and a causality assessment which will be included as part of the Individual Case Report.

• Conduct Individual Case Reviews (ICRs) in the Global Safety Database for both clinical trials and post-marketing environments, focusing on cases that meet the scope criteria to identify rare, severe, and potentially drug-related index cases that may prompt signal evaluation.

• Perform Medical Devices and Combination Products Reportability Assessment to determine whether ICSRs meet the criteria for expediated reporting to heath authorities.

• May request additional information deemed important for medical review

• Ensure compliance with global expedited reporting timelines with timely case assessment

• Under the direction of the ICMR Director (TAL) and/or the Executive Director, perform Analysis of Similar Events (AOSE) when applicable

• May participate in quality review of ICSRs from other ICMR team members

• May lead and/or participate in cross-functional projects as the ICMR subject matter expert, contributing to continuous process improvement of ICSR assessments

• Consult with the Clinical director for the trial and with the Clinical Safety and Risk Management Physician, as needed, for cases requiring additional clinical or safety subject matter expertise

• May participate in the training of the specified ICMR Team
• May participate in process, quality, innovation, technology, and other business-related activities
• May participate on special projects or rotational assignments within or outside of ICMR as part of their professional development

The ICMR Physician will work closely and collaboratively with colleagues in other departments in the Company, including but not limited to: Clinical Safety Scientists, Clinical Directors in Clinical Research, CSRM Physicians, and CSRM Associates and Scientists, Global and US Pharmacovigilance and Global Pharmacovigilance Case Management. The ICMR Physician will be a core member of the Risk Management Safety Teams (RMSTs) for the products they support, as well as other relevant sub-teams.

Education Requirement:

M.D. (Degree in Medicine)

Required Skills:

• Minimum of 1 year experience in clinical medicine following training, with 3 years of experience preferred; this experience is required in patient care settings

• A minimum of 3 years of relevant work experience that may include both clinical medicine practice post-training and pharmaceutical industry experience required
• The candidate must have a strong understanding of scientific and medical concepts
• Excellent writing and communication skills in English required
• Effective presentation skills and experience influencing and negotiating required
• Computer skill required- use of database and basic MS Office suite applications
• Problem-solving, conflict resolution, and critical thinking skills are required

Preferred Experience and Skills:

• Medical specialization

• Experience in drug safety, pharmacovigilance and/or risk management is highly desirable

• Prior medical review and/or case management experience

• Relevant Safety Systems Experience (i.e., Argus, ARIS-G, etc.)

• Drug development experience (early or late phase clinical research, regulatory affairs, and/or safety/PV)

• Demonstrated leadership skills in managing programs & processes, leading meetings, and influencing peers and direct reports to drive results
• Experience working and collaborating with global teams

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.